The RegIntelHub Weekly

Global PV updates, distilled - powered by our community

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👇 Start with the 10-Second Summary, then dive deeper if something touches your portfolio.

⏱️ 10-Second Summary (Read This First)

If you read nothing else this week:

Details and links below 👇

👀 This Period's Highlights

🇩🇿 Algeria — ANPP issues implementation notes on GVP and QPPV obligations

The National Agency for Pharmaceutical Products (ANPP) published two notes — No. 29 and No. 30/2026, both dated 16 March 2026 — setting out how pharmaceutical companies are expected to apply the Algerian GVP Guide in practice, and clarifying what is required from a QPPV or Local PV Representative standpoint.

• Every pharmaceutical establishment must maintain an adequately structured PV system and ensure a QPPV or Local PV Representative (RLPV) is permanently available
• Contact details for the QPPV or RLPV must be submitted to ANPP within 30 days of these notes, using the designated form sent by email to sd.vigilance@anpp.dz
• The requirement for the QPPV to hold a pharmacy or doctor of pharmacy qualification applies to new or developing PV systems only — companies with an existing operational system do not need to change their QPPV's profile, provided they can demonstrate this

What to do:

• Identify your QPPV or RLPV for Algeria and submit their contact details to ANPP within 30 days — this is the immediate priority
• If your PV system in Algeria is already operational, gather the documentation needed to demonstrate that — you may need it to avoid being asked to change your QPPV profile
• Review your PV system setup against the Algerian GVP Guide to confirm it meets the structural requirements described in the notes
• Update internal country trackers and local contact lists accordingly

🇮🇩 Indonesia — BPOM issues new PV regulation, replacing 2022 framework

Indonesia's Food and Drug Authority (BPOM) has published Regulation No. 4 of 2026 on the Implementation of Pharmacovigilance, replacing BPOM Regulation No. 15 of 2022 in its entirety. Several reporting requirements have changed materially — any company with marketed products in Indonesia needs to review this against their current setup.

• Non-serious adverse events and ADRs must now be reported within 90 calendar days — previously these fell under a 6-month line listing requirement
• Lack of efficacy (LoE) cases with no associated adverse event are now reportable — this is a new obligation not present in the 2022 regulation
• The zero report frequency has changed to once per year — companies previously submitting more frequently should adjust their schedules

What to do:

• Review your Indonesia reporting workflows against the three key changes above — timeline, LoE scope, and zero report frequency
• Update SOPs and submission schedules to reflect the 90-day non-serious AE deadline
• Ensure your case intake process captures LoE cases without a co-reported AE — these now need to flow into your reporting system
• Adjust your zero report calendar to annual frequency if you have been submitting more often

Also this week:

🇧🇾 Belarus — The national PSUR submission list has been updated to Version 18, dated 10 March 2026 and published on 16 March 2026. If you have products registered in Belarus, cross-check your portfolio against the new version for any changes to submission timelines or frequencies.

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⚖️ Disclaimer
This newsletter is for informational purposes only and does not constitute professional or legal advice.
All summaries are based on publicly available regulatory information. Always verify requirements with the relevant authority or qualified professional before implementation.
RegIntelHub assumes no liability for actions taken based on this content.